Pharmacovigilance data

GL42 Pharmacovigilance Data elements Pharmacovigilance Data Elements for Submission of Adverse Events Reports... 

Lawrenson, RA. et al., Liver damage associated with minocycline use in acne A systematic review of the published literature and pharmacovigilance data, Drug Safety, 23, 333, 2000. 

Similarly, where there are public health concerns as a result of pharmacovigilance data, nationally authorized products or products authorized by the mutual recognition procedure may be referred rmder Articles 12 or 15 of Directive 75/319/EEC. The CPMP/CVMP gives an opinion on variation, suspension, or withdrawal of the marketing authorization in such cases. 

This guideline lays down the requirements and procedures for national competent authorities regarding the collection, evaluation and management of pharmacovigilance data on medicinal products, however authorised in the community. 

Post-marketing surveillance and pharmacovigilance data contain few convincing cases of withdrawal from zopiclone. Most consist of rebound insomnia, but there are a few instances of withdrawal convulsions following high-dose dependence. A review of 25 zopiclone discontinuation studies found rebound effects and withdrawal symptoms to be minimal [35],... 

Coulter DM, Bate A, Meyboom RH, Lindquist M, Edwards IR. Antipsychotic drugs and heart muscle disorder in international pharmacovigilance data mining study. BMJ 2001 322(7296) 1207-9. 

Mann R, Mackay F, Pearce G, Freemantle S, Wilton L. Losartan a study of pharmacovigilance data on 14 522 patients. J Hum Hyperteus 1999 13(8) 551-7. 

Observational studies Analysis of postmarketing pharmacovigilance data with modified signal detection methods was performed to compare the adverse event... 

Psychiatric Hallucinations, delirium, manic episodes, and depression have been reported in pharmacovigilance data from several European countries these adverse reactions are rare and appear to be reversible on withdrawal [72 ]. 

Systematic reviews In a review of 20 trials (four in prophylaxis, 12 in treatment, and four in postexposure prophylaxis), oseltamivir caused nausea (OR = 1.79 95% Cl = 1.10, 2.93) evidence of rarer adverse events from pharmacovigilance data was of poor quality and such events may in any case have been under-reported psi ]. 

GL35 Pharmacovigilance ESTD Pharmacovigilance Electronic Standards for Transfer of Data... 

The term pharmacovigilance has now been adopted by all Member States for the activities involved in the study and evaluation of drug safety. Although pharmacovigilance covers a broad range of data collection methods, it is the spontaneous reporting systems sponsored by all European governments to which the term usually refers. 

Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRS) and Medicinal Product Reports (MPRS) in Pharmacovigilance during the Pre-and Post-Authorisation Phase in the EEA (EMEA/115735/2004) (Eudra Vigilance TIG adopted September 2004)... 

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